Barriers to Physical Activity in People With Type 2 Diabetes (Rxercise)
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Exercise, Rate of Perceived Exertion
Eligibility Criteria
Inclusion Criteria:
- Sedentary men and women not participating in a regular exercise program (> 60 minutes of exercise per week)
If subject has diabetes,
- must be uncomplicated type 2 diabetes (T2D) and
- <15 years since T2D diagnosis.
- Ages of 50-70 years
- BMI between 25 and 35
Subjects can only be taking the following oral hypoglycemic drugs:
- metformin,
- sulfonylureas or
- sitagliptin.
- Persons with T2D only if they have total glycosylated hemoglobin levels (HbA1C) <8.0% (adequate control) on therapy.
Control subjects must have:
- HbA1C < 5.7% and
- a fasting blood glucose of <100 mg/dl suggesting no significant insulin resistance.
- All women must be post-menopausal, documented by menstrual history and follicle stimulating hormone (FSH) level.
- Those who have quit smoking for at least 1 year will be accepted.
- Absence of comorbid conditions that could affect exercise will be confirmed by history, physical examination and laboratory testing.
Exclusion Criteria:
Persons with clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded from further study as neuropathy may limit exercise performance.
- Specifically, if monofilament sensation is absent at the level of the ankles, then participants will be excluded from study participation.
- Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded as well, due to associated limitations of exercise performance.
- Current use of insulin or other oral hypoglycemic medications.
- Current smokers will be excluded since smoking can impair cardiovascular (CV) exercise performance
Persons will be excluded if they have:
- evidence of heart disease by history (Prior heart attack or bypass surgery, heart failure, or significant valvular disease) or
- abnormal resting electrocardiogram (EKG) consistent with prior infarct or latent ischemia (unless cardiovascular stress imaging or catheterization shows they do not have coronary artery disease).
- left or right bundle branch block on resting EKG (precludes recognition of ischemic EKG changes with exercise) or
- abnormal exercise EKG (> 1 mm ST segment depression 80 msec out in the ST segment for 3 consecutive beats).
- Persons with angina or any other exercise-limiting cardiovascular, pulmonary or musculoskeletal symptoms.
Presence of:
- systolic blood pressure >145 mm Hg at rest or >250 mm Hg with exercise or
- diastolic blood pressure >90 mm Hg at rest or >115 mm Hg with exercise.
Subjects with:
- proteinuria (urine protein >220 mg/dl) or
- creatinine > 1.6 mg/dl, suggestive of renal disease.
Subjects with:
- total cholesterol >220 mg/dl,
- low density lipoprotein > 130 mg/dl, or
- triglycerides > 250 mg/dl, will be excluded given the potential insulin resistance and endothelial dysfunction associated with these cholesterol parameters.
- Control subjects who have more than two immediate family members with type 2 diabetes.
Chronic obstructive pulmonary disease demonstrated by a ratio of
- Forced Expiratory Volume in 1 second (FEV1),
- Forced Vital Capacity (FVC) < 0.70, or
- FEV1 <70% predicted during spirometry.
- Persons weighing more than 300 pounds will be excluded as this exceeds the weight capacity of our Dual Energy X-ray Absorptiometry device
- Participants with moderate cognitive impairment (Folstein Mini-Mental Status Examination (MMSE) score <24).
Sites / Locations
- University of Colorado, Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
An Active Comparator exercise training intervention
A Placebo Attention Control
The Active Comparator Groupwill participate in an exercise training intervention to distinguish the relative roles of objective factors (lactate level) and subjective factors (self-efficacy) in mediating pre-post change in RPE during low, moderate, and vigorous exercise.
The placebo attention control group will receive monthly diabetes education and phone calls phone calls to monitor their blood glucose levels. Participants will receive an accelerometer to wear for one week.